Adolor Corp., of Exton, Pa., said at the Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference in New York that it began enrollment in two additional Phase III trials of alvimopan, its small-molecule opioid receptor antagonist, for the management of post-operative ileus. Each double-blind and placebo-controlled trial is expected to include 450 patients at about 30 centers worldwide. The first Phase III of alvimopan for this indication was initiated in March. (See BioWorld Today, March 20, 2001.)
Biomira Inc., of Edmonton, Alberta, initiated a pilot Phase II trial evaluating the safety of Theratope vaccine in patients with metastatic colorectal cancer, as well as evaluating the ability of the vaccine to induce an antibody response in patients when given in combination with first-line chemistry. About 20 patients are expected to enroll and enrollment is anticipated to be complete near the end of the year. Theratope also is in a Phase III trial for women with metastatic breast cancer.
BSKB Medical Ventures LLC, of Costa Mesa, Calif., said it exclusively licensed the rights to commercialize a technology relating to a new class of potential antibodies from California State University, Fullerton. The company formed Pyro Pharmaceuticals Inc. to exploit the technology and it closed a Series A round of financing for an undisclosed amount in November. The technology comes from the work of Christopher Meyer at CSUF, who focuses on a metabolic pathway required for bacterial viability. Pyro said the company expects to receive patent coverage on the pathway and on selective drug candidates.
Cetek Corp., of Marlborough, Mass., signed an agreement with Tularik Inc., of South San Francisco, to develop assays and perform high-throughput screens for the discovery of lead compounds. Financial terms were not disclosed. Cetek has demonstrated that its core CE Assay is able to identify and rank the affinity of synthetic and natural product small molecules to therapeutic target proteins in a high-throughput environment, the company said.
ComGenex Inc., of Budapest, Hungary, opened a discovery center at the Fuzfo Industrial Park in Balatonfuzfo, Hungary. The facility will be a resource to expand core capabilities and extend ComGenexs current value-added discovery service portfolio, the company said. ComGenex focuses on developing discovery chemistry solutions through compound library design and synthesis of nonexclusive and exclusive libraries.
COR Therapeutics Inc., of South San Francisco, said The Journal of the American Medical Association reported that, one year following intracoronary stenting, patients who received Integrilin (eptifibatide) Injection in addition to traditional care continued to benefit from a reduction in the combined incidence of death or heart attack. Integrilin is the most-used agent in the class of antiplatelet agents known as intravenous GP IIb-IIIa inhibitors, COR said. The publication reported that the combined incidence of death or heart attack was reduced from 12.4 percent with placebo to 8.0 percent with Integrilin (p=0.0010). A consistency of benefit was reported regardless of patient age, weight, sex, clinical condition or presence or absence of diabetes.
Endovasc Ltd. Inc., of Montgomery, Texas, said it met with the FDA and reviewed its plans to submit an investigational new drug application for Nicotine Receptor Agonist. The IND will be filed in the first quarter of 2002. Following a review period by the FDA, the company anticipates initiating a Phase III trial to evaluate NRA as a treatment for chronic myocardial ischemia.
Genaissance Pharmaceuticals Inc., of New Haven, Conn., entered an agreement with Intec Web & Genome Informatics Corp., a Japanese bioinformatics and advanced-research business, to market all of Genaissances pharmacogenomics applications and products to pharmaceutical, diagnostic and biotechnology companies located in Japan. Financial details were not disclosed.
Genome Therapeutics Corp., of Waltham, Mass., reached two milestones in its genomics-based alliance with Schering-Plough Corp., of Madison, N.J., to develop products for the prevention and treatment of asthma. The milestones triggered undisclosed payments to Genome Therapeutics. The multiyear program, made public in 1996, focuses on asthma. If all milestones are attained, total payments to Genome Therapeutics, excluding royalties, could exceed $80 million, of which approximately $37 million has been received.
Immune Network Ltd., of Vancouver, British Columbia, entered an affiliation with Canvac, the Canadian Network for Vaccines and Immunotherapeutics, that will focus on the development of Immune Networks immune modulation therapies. Financial details were not disclosed.
Karo Bio USA Inc., a wholly owned subsidiary of Karo Bio AB, of Huddinge, Sweden, and GPC Biotech AG, of Martinsried, Germany, said their technology collaboration successfully concluded in 15 months with the development of 10 BioKey molecular probe assays for selected novel genomics-derived antibacterial targets owned by GPC. Karo Bio received undisclosed milestone payments for the completion of the assays. The 10 BioKey molecular probe assays provide GPC with a drug discovery engine to identify lead compounds with antibacterial activity.
LION Bioscience AG, of Heidelberg, Germany, and Nestle SA said they expanded their existing collaboration to cover the implementation of the first phase of an IT-based knowledge management system. Also, the agreement provides for the implementation of LIONs Web-Based Training Bioinformatics as an educational solution for the application of bioinformatics tools and concepts throughout Nestle. Financials details were not disclosed.
Morphotek Inc., of Philadelphia, and The Wistar Institute entered a collaborative research and development agreement to develop improved monoclonal antibodies. Morphotek will apply its Morphodoma technology to Wistar hybridoma cell lines in order to create second-generation hybridomas that produce monoclonal antibodies for the diagnosis and treatment of cancer and other diseases. Wistar and Morphotek will jointly own the second-generation hybridomas. Financial details were not disclosed.
Nabi, of Boca Raton, Fla., settled its arbitration with Baxter Healthcare Corp., of Deerfield, Ill., involving Nabis contract to supply antibodies to Baxter. This contract was assigned in connection with the sale of the operating assets of a majority of Nabis antibody collection business. Financial terms of the settlement were not announced.
Organogenesis Inc., of Canton, Mass., said it plans to raise about $15 million through the sale of equity securities in a private placement. The company filed an 8-K with the SEC on Jan. 30 describing the proposed financing. Organogenesis lead product, Apligraf, is approved for the treatment of venous leg ulcers and diabetic foot ulcers.
Ortec International Inc., of New York, said the FDA approved a pivotal trial using the cryopreserved version of OrCel to treat diabetic foot ulcers. The study is expected to be conducted at 25 clinical centers in the United States and involve 250 patients; enrollment is expected to begin by midyear. Ortec has a pivotal trial under way using the cryopreserved version of OrCel to treat venous leg ulcers.
Stratagene, of La Jolla, Calif., said The United States District Court for the Western District of Texas (Austin Division) issued final judgment on Jan. 31, in favor of Stratagene in its suit with Invitrogen Corp., of San Diego. Invitrogens allegations that Stratagenes competent cell products infringe a patent have been dismissed in their entirety, the company said. Invitrogen originally sued Stratagene, accusing all of its competent cell products of infringing U.S. Patent No. 4,981,797.
Panacos Pharmaceuticals Inc., of Gaithersburg, Md., raised $5 million through a private placement of Series B preferred stock to Ampersand Ventures, of Wellesley, Mass., and A. M. Pappas & Associates, of Research Triangle Park, N.C. Panacos will use these funds to initiate clinical development of its lead HIV drug candidates and to continue building its drug discovery program and pipeline of antivirals, the company said. Also, Panacos moved into a 10,000-square-foot facility in the Avenel Business Park in Gaithersburg. Finally, it completed the assembly of its core senior management team, consisting of Graham Allaway as president and CEO, Carl Wild as chief science officer, David Martin as vice president for drug development and Donald Zelm as chief financial officer.
Paradigm Genetics Inc., of Research Triangle Park, N.C., delivered to Bayer AG, of Leverkusen, Germany, several high-throughput screening assays for the identification of herbicides, receiving an undisclosed milestone payment. The original herbicide partnership began with the objective of discovering a portfolio of herbicide products that will be developed and marketed by Bayer. The three-year agreement included an option for two years that would take the collaboration to October 2003, which Bayer exercised in June 2001. Under this new expanded agreement, the companies will collaborate on herbicide discovery for up to an additional five years. (See BioWorld Today, June 20, 2001.)
Signature BioScience Inc., of Hayward, Calif., completed the acquisition of PrimeCyte Inc., of Seattle, in a deal that was valued at between $10 million and $20 million at the time of announcement. The acquisition advances and benefits Signatures detection-based, cell-oriented drug discovery platform, WaveScreen, Signature said. The acquisition was announced in early January. (See BioWorld Today, Jan. 9, 2002.)
Polycystic Kidney Disease Foundation, of Kansas City, Mo., said researchers at the Mayo Clinic identified and characterized the gene that causes autosomal recessive polycystic kidney disease, raising hopes of a treatment and perhaps a cure for infants born with the disease. The Polycystic Kidney Disease Foundation provided grants for the discovery of the PKHD1 gene, an effort aided by earlier work done at the Human Genome Project. The March 2002 issue of Nature Genetics will feature this discovery.
Repligen Corp., of Needham, Mass., initiated a clinical trial to assess the neurological activity of secretin by functional magnetic resonance imaging. The study is being conducted in collaboration with the Brain Imaging Center at McLean Hospital, a teaching affiliate of Harvard Medical School. The trial will assess the impact of a single injection of secretin or placebo on the activity of the amygdala, a social integration center in the brain, in 12 healthy adults. Subjects also will perform facial recognition tasks to determine if a single injection of secretin affects social awareness. This study is part of a program to evaluate secretin for the improvement of social interaction in children with autism.
Silico Insights Inc., of Woburn, Mass., is collaborating with Genzyme Molecular Oncology, a division of Genzyme Corp., of Cambridge, Mass., to identify and characterize oncogenic pathways and new drug targets with an initial focus on breast cancer. The companies will use data from Genzyme Molecular Oncologys SAGE database in combination with Silico Insights pathway elucidation platform. Financial details were not disclosed.